Q2 2024 Earnings Summary
- Immunology products like Sotyktu are underperforming expectations due to slower-than-expected market access and intense competition, with performance being "slower than we would like" and challenges in gaining preferred status with PBMs.
- Key growth drivers are facing increasing competition, with competitors running head-to-head trials that may lead to drugs with better efficacy than BMY's Sotyktu and Opdualag, and the market is becoming "more crowded and competitive over time."
- The company is moving away from providing long-term targets or floor guidance, potentially indicating uncertainty about future revenue streams, which may concern investors seeking visibility into future performance, especially given upcoming challenges like patent expirations and the impact of the IRA.
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IRA Impact on Eliquis
Q: Any updates on IRA negotiations for Eliquis?
A: We have received the government's final MFP price for Eliquis and expect CMS to publish it by September 1. Once published, we'll provide more details on the impact. Having seen the final price, we're increasingly confident in our ability to navigate the impact of the IRA on Eliquis, which remains important for patients and the company in the short to medium term. -
Sotyktu Performance and Pricing
Q: How is Sotyktu's pricing and performance outlook?
A: Sotyktu's performance has been slower than we'd like, but we're focused on improving it. We've increased access from 25% to 65% as of July 1, covering over 100 million lives. Further access improvements are expected in January. While there will be a modest increase in gross to net due to rebates for improved access, this is offset by increased volume. We're committed to making this a big product as we move into 2025. -
Business Development Strategy
Q: What's your capacity and focus for business development?
A: Business development remains a priority. We're focused on executing recent deals, like preparing for the KarXT launch. Paying down debt is also a top priority. We're interested in deals that make strategic and financial sense, focusing on therapeutic areas where we have a right to win. We plan to pursue bolt-on deals and partnerships. We're monitoring the obesity market but are currently focusing on our highlighted areas. -
Opdivo Subcutaneous Launch
Q: How will the Opdivo subcutaneous version impact the business?
A: We anticipate the PDUFA date for Opdivo subcutaneous in late December. We aim to convert at least 30%–40% of the total U.S. Opdivo IV business before the 2028 LOE. This new formulation benefits patients with less than 5-minute infusion time and frees up chairs for physicians. We expect both subcutaneous and IV versions to continue into the next decade, extending our leading IO franchise into the early 2030s. -
Cendakimab Launch Plans
Q: When can we expect the cendakimab launch?
A: We recently had a positive Phase III study for cendakimab in Eosinophilic Esophagitis (EO), meeting both primary endpoints. We've just received the data and are analyzing it. In the U.S., there are about 300,000 treated EO patients with low treatment rates. We expect cendakimab to be positioned behind Dupixent, and we're preparing to share data with regulatory authorities and present at an upcoming meeting. -
Breyanzi Performance
Q: Can you discuss Breyanzi's strong quarter and outlook?
A: Breyanzi sales increased over 50% versus prior year in Q2. We've expanded manufacturing capacity, putting us in a stronger position to meet demand. Growth will continue, driven by our leading indication in LBCL and recent expanded indications. Breyanzi is increasingly recognized as a best-in-class CD19 therapy. -
Operating Margin Outlook
Q: How should we think about 2025 operating margins?
A: We remain committed to an operating margin greater than 37%. We saw strength in our gross margins with a favorable mix, and our operational efficiency programs give us flexibility in maintaining those margins. -
Part D Redesign Impact
Q: How will Medicare Part D redesign affect your products?
A: We'll see favorability with Eliquis due to the Part D redesign, notably the elimination of the coverage gap, partially offset by increased responsibility in the catastrophic phase for products like Revlimid and Pomalyst. Overall, when looking at Part D redesign across the portfolio, we think it offsets and will largely move on. -
Milvexian and FXIa Program
Q: Any concerns with Milvexian after competitor data?
A: We're confident in our Milvexian program. We chose doses based on prior learnings, including 100 mg BID for single agent. Independent investigators have shown differentiation between asundexian and Milvexian. Enrollment continues well in AF, secondary stroke prevention, and ACS trials, and we're looking forward to readouts. -
Camzyos Performance
Q: Can you discuss Camzyos patient growth trends?
A: We're seeing steady and consistent growth with approximately 1,300 patients added quarter-over-quarter. Physician and patient feedback remains positive. We're increasing our user base in large COEs and expanding prescribing in smaller institutions and community practices. We're deploying additional community representatives to drive treatment. -
PRMT5 Data Expectations
Q: What will we see from the PRMT5 readout?
A: We plan to present data from our PRMT5 program this year at a medical conference, including responses across multiple tumor types. This will help as we initiate Phase II studies in selected patients with MTAP deletions. -
Radiopharma Strategy
Q: How do you view the radiopharma opportunity with RayzeBio?
A: We're excited about the RayzeBio platform, which includes a robust IND engine and a state-of-the-art manufacturing facility. While the lead program Rayze 101 in GAP-NET is a modest opportunity, the actinium-based radiopharmaceutical platform has potential across a host of solid tumors. We look forward to launching Rayze 101 and advancing new INDs in the back half of the decade and beyond. -
CELMoDs Positioning
Q: How will your CELMoDs compete in multiple myeloma?
A: Our CELMoDs, Iberdomide and Mezigdomide, are in development across four Phase III trials with readouts in 2026. We're focusing on multidrug regimens for better outcomes. Mezigdomide is going head-to-head versus pomalidomide, and Iberdomide is being studied in combinations and as maintenance after transplant versus Revlimid. We believe they will play roles, especially in patients not eligible for cell therapies, providing manageable toxicities and more options for physicians. -
Sotyktu Competitive Landscape
Q: How will Sotyktu fare against new competitors?
A: We recognize psoriasis is a highly competitive category that will become more crowded over time. Sotyktu has set a high bar for new orals. We're preparing for competition and plan to have several indications, including psoriatic arthritis (PsA) and SLE, which will help accelerate Sotyktu's growth. We're focused on growing this important brand. -
CAR NEX-T Data
Q: Any updates on the CAR NEX-T program?
A: We have two ongoing studies with our CD19 NEX-T therapy. One enrolls patients with advanced systemic lupus erythematosus and other autoimmune diseases; the other enrolls patients with multiple sclerosis. We aim to achieve remission, allowing patients to discontinue treatments like glucocorticoids and immunosuppressants. We look forward to presenting data and progressing the program.